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By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy

Efficacy of Surgical Coronary Revascularization Associated With Stem Cells Injection in Patients With Severe Chronic Ischemic Heart Disease With Residual Viability. A Prospective, Controlled Pilot Trial.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00690209
Enrollment
12
Registered
2008-06-04
Start date
2008-05-31
Completion date
2013-01-31
Last updated
2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Chronic ischemic cardiomyopathy with residual viability, surgical coronary revascularization, stem cell therapy, Chronic ischemic heart disease, severe impairment of global contractility left ventricular dilation, residual viability

Brief summary

Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of \> 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization. Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.

Detailed description

The screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose. Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria. Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories. During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.

Interventions

PROCEDUREAutologous bone marrow derived stem cells myocardial transplantation

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Chronic ischemic heart disease * Left ventricular dilation (end systolic volume \>140 ml) * Poor global contractile function (ejection fraction \<40%) * Substantial amount of residual viability (\>30% of left ventricle)

Design outcomes

Primary

MeasureTime frame
Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility

Secondary

MeasureTime frame
Functional status

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026